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RecruitingPhase 2NCT06291064

Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)

Sponsor

University of Chicago

Enrollment

85 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Summary

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC). All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria15

  • Women ages of 18 to 70 years old
  • Women who are able and willing to read understand and sign an informed consent document
  • Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
  • Patients with histologically confirmed carcinoma of the female breast with triple-negative status by immunohistochemistry (IHC). Patients who are low estrogen reception (ER) expression (\< 20%), progesterone receptor (PR) negative and human epidermal growth factor 2 (HER2) negative are eligible.
  • Clinical stages IIA -IIIC (AJCC 2009)
  • Chemotherapy-naïve patients (for this cancer)
  • Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Non-pregnant and not nursing.
  • Granulocyte greater than or equal to 1,500/microliter
  • Platelet count greater than or equal to 100,000/microliter
  • Absolute neutrophil count (ANC) greater than or equal to l500/microliter
  • Hemoglobin greater than or equal to 10g/deciliter
  • Bilirubin less than or equal 1.5 x upper limit of normal
  • aspartate aminotransferase (ALT or SGOT) and alanine transaminase (AST or SGPT) less than 2.5 x upper limit of normal
  • \. Creatinine within institutional normal limits or glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation 10. Baseline left ventricular ejection fraction of greater than or equal to 55%

Exclusion Criteria6

  • Pregnant or lactating women.
  • Patients with distant metastasis (brain and/or visceral metastasis)
  • Serious, uncontrolled, concurrent infection(s).
  • Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment
  • Other serious uncontrolled medical conditions that the treating investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.

Interventions

DRUGCyclophosphamide

Cyclophosphamide is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Epirubicin.

DRUGEpirubicin

Epirubicin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide.

DRUGDocetaxel

Docetaxel is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Carboplatin. Dosing will start after treatment with Epirubicin and Cyclophosphamide (EC) is completed.

DRUGCarboplatin

Carboplatin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Docetaxel. Dosing will start after treatment with EC is completed.

PROCEDUREBreast Surgery

Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.

DRUGCapecitabine

Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.

Locations(4)

Lagos State University Teaching Hospital

Ikeja, Lagos, Nigeria

Lagos University Teaching Hospital

Yaba, Lagos, Nigeria

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, Nigeria

University of Ibadan Hospital

Ibadan, Oyo State, Nigeria

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NCT06291064